Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of ‘food as medicine’ to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). We plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) to patients with HFrEF and malnutrition. We hypothesize that home delivery of MTMs will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The first phase of the proposed pilot study will asssign participants to a 12-week MTM phase only. The second phase is a randomized crossover trial, in which each subject receives a 12-week standard of care phase with self-directed dietary intake and a 12-week MTM dietary intervention phase, with a 4-week washout period between the two phases. Meals will be designed, prepared and delivered by our community based organized partner, Community Servings. We will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of MTM for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.
- Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms with at least one prior hospitalization for heart failure in the preceding 12 months and evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
- Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the medically-tailored meal deliveries
- For females: not currently pregnant and not imminently planning a pregnancy
- Prior heart transplantation or implantation of a left ventricular assist device
- Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings
- Systolic blood pressure at screening <90 mmHg, or heart rate >110 bpm
If you decide to take part in this research study, you will be asked to sign this consent form. You will then undergo a study testing visit, lasting approximately 2 hours, with the procedures listed below. The same study tests will be performed twice and will each last 2 hours: once before starting the 12-week medically-tailored meal phase and once just before the end of the 12-week medically-tailored meal phase. We will also make a telephone call after 2 weeks into the medically-tailored meal phase to check how the food plan is working out for you and whether you have any concerns or recommendations for changes.
Study testing visits include: a medical history, 30 ml (3 tablespoons) of venous blood, hand-grip strength test, a 6-minute walk test, a sit-to-stand test, a questionnaire about heart failure symptoms, questionnaires about appetite, current food and opinions on the diet, and a 2-week activity monitor.
The medically-tailored meals (MTMs) will be delivered weekly in a pre-prepared form by a non-profit group called Community Servings. Deliveries are contactless during the COVID-19 pandemic. Handouts with meal information will not be provided to research subjects. Participants will need to refrigerate the food once it arrives at your home address and then unpackage and/or heat it as appropriate for each meal. You will be supplied with food for 5-days of the week (i.e. weekdays only, not weekends). The food supplied includes 2 meals per day, plus snacks. You are permitted to consume food other than that supplied in your food deliveries as a third meal during the day and also to consume your own food supply on the weekends.